A Prospective Multi-Centre Evaluation of Gastrostomy in Patients with
Motor Neuron Disease (PROGAS).

Motor neuron disease (MND) is a devastating illness which leads to progressive muscle weakness and eventual death, usually within 3 years. Difficulty in swallowing is a common problem in patients with MND. Patients with severe swallowing difficulty experience malnutrition, dehydration, choking and an increased risk of chest infections. Traditional use of nasal gastric tubes for feeding are problematic for MND patients and is not compatible with using Non-Invasive Ventilation (NIV).

Long-term nutritional support of patients with severe swallowing difficulty can be achieved by placing a feeding tube, known as a gastrostomy, directly into the stomach. However, the current practice of gastrostomy feeding is largely based on consensus and expert opinion rather than the outcomes of appropriately designed trials. Currently gastrostomy technique and timing of insertion within the disease course vary throughout the UK. There is a lack of evidence to suggest what the optimal timing for gastrostomy is, or which method is most appropriate. In addition, although gastrostomy is routinely performed, the benefits, such as improved survival and quality of life following gastrostomy, have not been proven.

The main aim of this study is to develop evidence-based guidelines for
gastrostomy use in patients with MND.

Patients and carers will be recruited at the participating MND Centres around the UK. Questionnaires will be used to assess the safety, complications and benefits of the differing timings and methods of gastrostomy insertion. Participants recruited at the Sheffield MND Centre will take part in an additional interview study, to further explore the perceptions and experiences of patients and carers with regard to the impact of gastrostomy on quality of life. The results of this work will translate into the development of guidelines, which will optimise the benefit, and the patient and carer experience of gastrostomy. The principles will be readily applicable to patients with severe swallowing problems who are eligible for gastrostomy insertion due to other neurological diseases.

This study is aiming to look at three alternative gastronomy feeding tube insertion techniques and to assess the safety, complications and benefits of the differing timings and methods.

The three methods being assessed are:

• Percutaneous Endoscopic Gastrostomy (PEG).
• Radiologically Inserted Gastrostomy (RIG).
• Per-oral Image-guided Gastrostomy (PIG).

The aim of the study is to develop evidence-based guidelines by identifying:

• Optimal technique and timing.
• Effect on survival and nutritional status.
• Effect on quality of life.

The large nationwide study with 20 MND Care Centres and Clinics on board  will recruit 780 patients over 2 years. The study consists of a 12-month patient follow up  including baseline, 3-month, 12-month assessments using quantitative questionnaires and qualitative interviews.

The study has now been fully recruited to and is in follow-up.

Funding:
The study is funded by the Motor Neurone Disease Association and SITraN.

For more information:
Please visit the UK Clinical Research Network Portfolio or DeNDRoN

References:

1. Gastrostomy use in motor neurone disease (MND): A review, meta-analysis and survey of current practice. Theocharis Stavroulakis, Theresa Walsh , Pamela J. Shaw & Christopher J. McDermott (on behalf of the PROGAS study). Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. 2013 Mar;14(2):96-104.doi:10.3109/17482968.2012.723722. Epub 2012 Sep 17.
2. Factors influencing decision-making in relation to timing of gastrostomy insertion in patients with motor neurone disease. Stavroulakis T¹, Baird WO, Baxter SK, Walsh T, Shaw PJ, McDermott CJ. BMJ Support Palliat Care. 2014 Mar;4(1):57-63. doi: 10.1136/bmjspcare-2013-000497. Epub 2013 Dec 11.
3. The impact of gastrostomy in motor neurone disease: challenges and benefits from a patient and carer perspective. Stavroulakis T¹, Baird WO², Baxter SK², Walsh T¹, Shaw PJ¹, McDermott CJ¹. BMJ Support Palliat Care. 2014 May 21. pii: bmjspcare-2013-000609. doi: 10.1136/bmjspcare-2013-000609. [Epub ahead of print]